October 29, 2018Psychiatry
Editor's Note: Evidence-base medicine is key to proper and medically justified treatments. The NIH again has shown us that it is all about the data, and not about "feelings." when we make decisions about medical interventions.
Delirium is an acute disturbance in attention and awareness with symptoms that can include disorganized thinking and agitation. More than 7 million hospitalized Americans per year experience delirium. It can affect patients of any age but is more common among older adults who experience major illness -- especially involving an ICU stay -- or have major surgery. Delirium is also associated with higher ICU costs and multiple adverse outcomes, such as longer hospital stays, long-term cognitive impairment and death.
According to a study published online in the New England Journal of Medicine (22 October 2018), critically ill patients in intensive care units (ICUs) did not benefit from two antipsychotic drugs used to treat delirium. The clinical trial found no evidence that treatment with antipsychotic medicines -- haloperidol or ziprasidone -- affected delirium, survival, length of ICU or hospital stay or safety. The findings are derived from the Modifying the Incidence of Delirium USA (MIND USA) study.
According to the NIH, antipsychotic medications have been used to treat delirium in ICU patients for 40 years without definitive understanding of their effectiveness. Therefore, to address the question of benefit versus risk of the use of antipsychotics for delirium, the MIND USA investigators, screened nearly 21,000 patients at 16 U.S. medical centers. Of the 1,183 patients on mechanical ventilation or in shock enrolled, 566 became delirious and were randomized into three groups: 1) intravenous haloperidol, 3) ziprasidone or 3) placebo (saline). Study endpoints included delirium and coma duration, time on mechanical ventilation, successful discharge from ICU and hospital, as well as 30- and 90-day mortality.
Results showed no significant differences in duration of delirium or coma among those participants on haloperidol or ziprasidone compared to placebo. Similarly, there were no significant differences among participants on either antipsychotic medication compared to placebo in 30-day and 90-day mortality or time on the ventilator, or in the ICU and hospital. The study population included participants with a wide range of ages, conditions and admission diagnoses. Overall, they had a 73% 30-day survival rate and 64% 90-day survival rate, which reflects the severe nature of their illnesses. The authors also found no evidence of major harm from the antipsychotics but did note other research suggesting safety concerns, including increased mortality associated with antipsychotic use in non-ICU geriatric populations.
The MIND USA researchers noted there is some evidence that medications such as dexmedetomidine or melatoninmay reduce both the prevalence and duration of delirium. The authors emphasized that reducing over-sedation and improving early mobility is another strategy.